🇺🇸 FDA
DSHEA dietary supplement; not GRAS; FDA warning letters on diabetes/cholesterol disease claims
Berberine (Berberis alkaloid)
Also known as: Berberine HCl · Berberine sulfate · Dihydroberberine (DHB)
Mechanism of action
- AMPK activation
- Hepatic gluconeogenesis suppression
- Gut microbiome modulation
- PCSK9 mRNA suppression (lipid effect)
Molecular + tissue targets
- Hepatic AMPK axis
- Glycemic regulation
- LDL-cholesterol pathway
- Gut microbiota
Dosage range
500 mg t.i.d. (1500 mg/day total) standard; dihydroberberine 100-200 mg/day better absorbed; take with meals
Safety notes
GI upset (constipation/diarrhea) common; CYP3A4/CYP2D6 inhibition (drug interactions · metformin, statins, immunosuppressants); contraindicated in pregnancy (uterotonic theoretical); not equivalent to metformin (despite popular framing)
Cross-market regulatory status
🇪🇺 EFSA
Not authorized as food supplement claim; Novel Food considerations
🇧🇷 ANVISA
RDC 243/2018 dietary supplement framework · IN 28/2018 alegação funcional not authorized
Common use cases
- glycemic regulation (research context)
- lipid management adjunct
- metabolic syndrome support
Cross-reference
Health goals: weight management heart health glp 1 companion
Lifestyles: glp 1 companion weight management
Full dossier: /ingredients/berberine/
Machine-readable JSON: /api/nc/berberine.json